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Generated: March 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203037

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NDA 203037 describes MONTELUKAST SODIUM, which is a drug marketed by Ajanta Pharma Ltd, Dr Reddys Labs Ltd, Mylan Pharms Inc, Teva Pharms, Anbison Lab Co Ltd, Apotex Inc, Aurobindo Pharma Ltd, Cspc Ouyi Pharm Co, Hetero Labs Ltd V, Jubilant Generics, Kremers Urban Pharms, Macleods Pharms Ltd, Sandoz Inc, Torrent Pharms Ltd, Unimark Remedies Ltd, Vintage Pharms Llc, West-ward Pharms Int, Accord Hlthcare, Amneal Pharms, Apotex Corp, Cipla Ltd, Glenmark Generics, Perrigo R And D, and Unichem Labs Ltd, and is included in forty-three NDAs. It is available from fifty-six suppliers. Additional details are available on the MONTELUKAST SODIUM profile page.

The generic ingredient in MONTELUKAST SODIUM is montelukast sodium. There are thirty-three drug master file entries for this compound. Fifty-nine suppliers are listed for this compound. Additional details are available on the montelukast sodium profile page.
Summary for 203037
Applicant:Unimark Remedies Ltd
Ingredient:montelukast sodium
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 203037
Suppliers and Packaging for NDA: 203037
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MONTELUKAST SODIUM montelukast sodium TABLET, CHEWABLE;ORAL 203037 ANDA West ward Pharmaceutical Corp 0143-9650 E 0143-9650-10
MONTELUKAST SODIUM montelukast sodium TABLET, CHEWABLE;ORAL 203037 ANDA West ward Pharmaceutical Corp 0143-9650 E 0143-9650-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrengthEQ 4MG BASE
Approval Date:Oct 30, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrengthEQ 5MG BASE
Approval Date:Oct 30, 2014TE:ABRLD:No

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